FDA recall D-0154-2025

Product

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-11-25

Report date

2024-12-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2025